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In the complex and highly regulated world of pharmaceutical manufacturing, effective risk management is not just a best practice: it is critical and necessary. Plant managers are tasked with ensuring product quality, patient safety, and regulatory compliance, all while maintaining operational efficiency and profitability.

A powerful tool in this challenging endeavor is the risk register.

This article explores the pivotal role of risk registers in pharmaceutical manufacturing and provides details on how they may be effectively implemented and used to enhance risk management processes. We will delve into the key components of a well-designed risk register, discuss best practices for its implementation, and highlight how this tool can drive continuous improvement in operations.

What is a risk register?

A risk register is a living document, similar to a Trace Matrix, used in pharmaceutical facilities as a risk management tool. The risk register serves as a repository for all risks identified within a pharmaceutical manufacturing facility and includes detailed information about each risk, including the current state of the risk and the risk mitigation plan and/or completed corrective action.

Why implement a risk register?

In addition to patient safety, there are several critical reasons for improving risk management through the utilization of risk registers.

Enhanced internal visibility and improved decision-making. A risk register provides a clear and comprehensive view for your team of the potential threats and enables proactive management. By systematically documenting risks and mitigation actions, pharmaceutical manufacturers gain a structured approach to risk assessment and prioritization. This process allows for more informed decisions for both resource allocation and risk mitigation efforts, ultimately leading to improved operational efficiency.

Facilitated regulatory compliance. Maintaining a detailed risk register is helpful for meeting regulatory requirements and demonstrating commitment to quality and safety to regulatory authorities such as the FDA, EMA, and ICH. The risk register serves as a centralized repository of risk-related information, making it easier to respond to regulatory inquiries and provide documented status updates for all risks being mitigated. This proactive approach streamlines inspections and audits, potentially reducing regulatory scrutiny.

Protection of product quality. A well-maintained risk register helps pharmaceutical manufacturers identify, control, and eliminate risks from their facilities, to maintain high standards of product quality. This is essential for ensuring the safety, identity, strength, purity, and quality (SISPQ) of products provided to healthcare providers and patients. By addressing potential risks before they impact production, manufacturers can consistently deliver high-quality medications.

Mitigation of financial and reputational risks. Pharmaceutical manufacturers understand that unmitigated operational risks have significant financial consequences. The average cost of a pharmaceutical product recall is approximately 10 million dollars. Additionally, the hours spent investigating “out of specification” (OOS) deviations and developing effective “corrective and preventive actions” (CAPAs) have cost associated with each occurrence. A comprehensive risk register helps protect against unidentified risks that could lead to unplanned shutdowns, manufacturing delays, and damage to brand reputation. By proactively managing risks, pharmaceutical companies can safeguard their financial stability and market standing.

Continuous improvement and knowledge management. Implementing a risk register fosters a culture of continuous improvement within the organization. By systematically tracking and addressing risks over time, pharmaceutical manufacturers can identify trends, learn from past experiences, and continuously refine their risk management processes. This accumulated knowledge is an asset, enabling more effective risk mitigation strategies and promoting overall operational excellence.

How to implement a risk register

The risk register should combine the outcome of site risk assessments and their mitigation strategies in a quick reference format. While there are various ways to present a risk register, one common and effective method is to use the Failure Mode, Effects, and Criticality Analysis (FMECA) format. However, organizations have flexibility in how they format  and present their risk registers.

The key requirements for any risk register format are:

• A comprehensive list. The register should include all significant risks identified by the organization.
• Risk tracking. Provide a means to track each risk over time.
• Mitigation summary. Outline how each risk is being mitigated or managed.

Some alternative formats include:

• Spreadsheets. Use of Microsoft Excel or Google Sheets.
• Database systems. Specialized risk management software or custom-built databases.
• Visual boards. Kanban-style boards for more visual representation of risks.
• Integrated quality management systems. The risk register is part of a larger quality and compliance platform.

Regardless of the specific format chosen, the risk register should align with the organization’s overall risk management strategy and integrate seamlessly with other quality management processes.

It is important that the chosen format allows for easy updating, clear communication of risks and mitigation strategies, and effective tracking of risk status over time—accessible and understandable to all relevant stakeholders within the organization.

Essential components of a risk register

A comprehensive risk register should include the following information for each identified risk:

• Risk ID: A unique identifier for each risk
• Risk description: A clear and concise explanation of the risk
• Risk owner: The individual or team responsible for managing the risk
• Existing controls: Current measures in place to mitigate the risk
• Risk likelihood: The probability of the risk occurring
• Impact: The potential adverse impact or consequences if the risk materializes
• Risk score: A quantitative measure combining likelihood and impact
• Risk rating or category: A classification of the risk (e.g., high, medium, low)
• Improvement actions: Planned strategies to further mitigate or eliminate the risk

Key risk areas to assess

When implementing a risk register, it’s crucial to consider all aspects of pharmaceutical manufacturing. Key areas to assess include:

• Facility design
• Clean room design
• Critical utilities design and aging
• Manufacturing new product introduction
• Manufacturing process
• Cleaning process
• Manufacturing support processes:
  • Standard Operating Procedures (SOPs)
  • Maintenance activities
  • Calibrations
  • System lifecycle (change controls and corrective and preventive actions)
• Raw data requirements. In light of the MHRA’s GXP Data Integrity Guidance and Definitions, all raw data requirements supporting the above-listed items should be carefully considered.

Implementation Process

The risk management team is typically cross-functional and responsible for overseeing the risk register implementation. Steps to kick-off the process include:

1. Populating the risk register. Enter all identified risks and their associated information into the risk register template from existing risk assessments. Fill in any gaps. Based on risk scores and categories, prioritize risks for mitigation efforts.
2. Developing mitigation strategies. For high-priority risks, develop detailed action plans to reduce or eliminate the threats. Clearly define ownership for each risk and associated mitigation actions.
3. Scheduling regular reviews and updates. Establish a schedule for reviewing—typically every 6 months– and updating the risk register, ensuring it remains a living document that reflects the current risk landscape.
4. Integrating with the quality management system. Ensure the risk register is integrated with the overall quality management system, including change control and CAPA processes.
5. Training and communication. Provide training to relevant staff on the use and importance of the risk register and establish clear communication channels for reporting new risks or changes to existing risks.

By following this structured approach to implementing a risk register, pharmaceutical manufacturers can create a robust tool for managing risks across their operations, ultimately enhancing product quality, patient safety, and regulatory compliance.

What Salas O’Brien’s clients report on using risk registers

Benefits

Clients report the biggest win from developing a site risk register is that they now have a single document detailing the complex multidepartment endeavor of risk management.  Other benefits include:

• Consistent application of critical and fact-based thinking across all site risk assessments.
• Less subjectivity when determining mitigation.
• Coordinates across all site disciplines and departments reducing the duplication of effort and increasing consistent methodology.
• Provides a de facto table of contents used to check if an existing risk assessment is in place (prior to writing a new one).

Challenges

Developing and managing a risk register takes time.  Much of that time is provided by high-level subject matter experts (SMEs) including plant engineering, process engineering, and regulatory / quality resources. Some of the tasks include:

• Resource management and scheduling = when can all the stakeholders meet?
• Achieving consensus on risk register method, format, contents, etc.
• Data mining and writing the risk register
• Reviews and approvals
• Establishing risk review cycles (revision control and frequency) and other standard operating procedures or work instructions for risk register maintenance.

How Salas O’Brien can help

Salas O’Brien provides comprehensive consulting engineering services to pharmaceutical manufactures. As a third-party entity, we can design and implement risk registers that align with your unique business model and operational needs. Our team recommends optimal formats and content structures to ensure your risk register is both comprehensive and user-friendly.

By partnering with Salas O’Brien, you gain access to a wealth of industry knowledge and best practices. Our tailored approach is designed to position your organization for proactive risk management to protect your bottom line, maintain market competitiveness, and easily respond to regulatory compliance.

For media inquiries on this article, reach out to Stacy Lake, Director of Corporate Communications.